Received Dec 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (PEDVAXHIB) | MERCK & CO. INC. | UNK | Y018677 | OT |
No additional AE; Patient received PEDVAX HIB after temperature excursion; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, past medications, and concomitant medications were not reported. Multiple temperature excursions occurred previously to vaccine administration (12-Sep-2025, 8.9 C for 15 minutes; 24-Sep-2025, 8.4 C for 8 minutes; 25-Sep-2025, and 8.2 C for 12 minutes). On 30-Sep-2025, the patient was vaccinated with an improperly storage dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) suspension for injection (valid lot number: Y018677, expiry date reported and confirmed as 10-Apr-2027; strength, dose, frequency, route and anatomical location not provided) for prophylaxis (product storage error). Reporter stated that zero patients who received the affected administered doses reported any adverse issues or side effects. This is one of multiple reports from the same reporter.